MAUDE Adverse Event Report: Bard Access Systems, Inc. PowerPort ClearVUE; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	5676301
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with new diagnosis of all "[acute lymphocytic leukemia]" requiring port placement.Patient placed on add on list thursday for procedure.Around 1430 after patient was npo "[nothing per os]" since 0000, surgery made team aware that there was no room for patient's procedure that day.Patient then placed on the schedule for friday at 11.When patient arrived in pacu "[post anesthesia recovery unit]", heme/onc "[hematology-oncology]" nurses requested to go to pacu to assist with labs as port was difficult to flush/ no blood return.Per pacu rn, port was accessed x2 in surgery d/t "[due to]" difficulty and was not heparin locked correctly.2 rn went to pacu and re-accessed port for a third time.Blood return only noted when patient was arching/upset and was still difficult to flush.Port was hep locked at this time and team made aware of difficulty.Patient arrived back to floor several hours later, and this rn received message from surgery team to hep lock/alteplase port and if that doesn't work, they would order xray.This rn attempted for blood return, and port was difficult to flush.This rn requesting xray prior to alteplase to check for placement.Xray showing port was kinked and surgery team made family aware he would be an add on again that night to go back for a revision.This delayed his chemo start date.Physician team has been reporting that these are tending to kink.Looking for alternative products.Manufacturer response for 6fr low profile port, (brand not provided) (per site reporter).

• Brand Name: PowerPort ClearVUE
• Common Device Name: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): Bard Access Systems, Inc.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 50944847
• Report Number: 50944847
• Device Sequence Number: 21207076
• Product Code: LJT
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2026
• Report Date (Section F): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5676301
• Device Catalogue Number: 5676301
• Device Lot Number: unknown
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/09/2026